There is a ‘c’ in ‘cGMP’ for a reason. Technology is always advancing; new methods are constantly being developed to improve quality, reliability, safety and reduce risk in pharmaceutical processing.
Some years ago Getinge La Calhène (through its then subsidiary Linac Technologies), introduced the SterStar, a system that uses an array of electron beams to biodecontaminate the external surfaces of tubs containing sterile ready-to-fill/ready-to-use (RTU) syringes as they pass into a barrier isolated filling line.
It was a revolution at the time, designed to feed high-speed production lines operating at up to 6 tubs/minute, or about 600 syringes/min.
The tubs pass through a ‘curtain’ of e-beam radiation as they feed continuously into the filling line, treating all the external surfaces of the tub uniformly and assuring a 6-log sporicidal reduction.
This had to be achieved without the e-beam penetrating the tub or beyond the first layer of the Tyvek lid, as to do so would negatively affect the glass containers inside.
A key identified challenge (and validation test) at the time was to assure this same 6-log reduction under the edge of the Tyvek lid, the critical area where the Tyvek is adhered to the tub flange.
When the lid is subsequently removed before filling, this flap is immediately adjacent to, and passes over the open necks of the sterile containers within the tub – hence the focus on this area.
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